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WO2001097887A1 - Administration d'agents stimulant les bronches - Google Patents

Administration d'agents stimulant les bronches Download PDF

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Publication number
WO2001097887A1
WO2001097887A1 PCT/GB2001/002648 GB0102648W WO0197887A1 WO 2001097887 A1 WO2001097887 A1 WO 2001097887A1 GB 0102648 W GB0102648 W GB 0102648W WO 0197887 A1 WO0197887 A1 WO 0197887A1
Authority
WO
WIPO (PCT)
Prior art keywords
bronchially
inhaler
medicament
delivery device
medicament delivery
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/GB2001/002648
Other languages
English (en)
Inventor
Philip Braithwaite
Leslie Hendeles
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Innovata Biomed Ltd
University of Florida
Original Assignee
Innovata Biomed Ltd
University of Florida
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Innovata Biomed Ltd, University of Florida filed Critical Innovata Biomed Ltd
Priority to AU2001266143A priority Critical patent/AU2001266143A1/en
Publication of WO2001097887A1 publication Critical patent/WO2001097887A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/0045—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/0045—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
    • A61M15/0046—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type of carrier
    • A61M15/0051—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type of carrier the dosages being arranged on a tape, e.g. strips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/06—Solids
    • A61M2202/064—Powder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6063—Optical identification systems
    • A61M2205/6081—Colour codes

Definitions

  • This invention relates to a novel delivery system and to a novel method of treating patients.
  • Methacholine is used in the clinical diagnosis of respiratory disorders, e.g. asthma, and for the evaluation of treatment effects.
  • methacholine chloride is delivered as an aqueous solution via a nebuliser or a dosimeter to a patient.
  • the methacholine chloride causes bronchoconstriction and the concentration at which bronchoconstriction occurs reflects the degree to which the patient may be suffering from a respiratory disorder.
  • the concentration that causes a 20% decrease in lung function (FENi) is- usually measured as the provocative concentration, or PC o or the provocative dose, PD o.
  • a healthy patient will have a high PC o or PD 2 o.
  • a medical practitioner will prepare a range of methacholine chloride solutions in saline, with a concentration of from 0.03 mg ml "1 to l ⁇ mg ml "1 .
  • a further disadvantage of the conventionally used diagnostic technique is that a patient must use a "communal" nebuliser or dosimeter.
  • a novel system for delivering methacholine, or a salt thereof, and other bronchially provocative agents which comprises the metering of the provocative agent in the delivery system used.
  • a single concentration of solution may be used and the amount of solution delivered may be varied.
  • a method of conducting a bronchial challenge test which comprises metering and subsequently administering a provocatively effective amount of a bronchially provocative agent to a patient.
  • bronchial challenge test it is intended to include a bronchial diagnostic test and/or evaluation of bronchial treatment effects, for example, PC 2 o or PD 2 o.
  • a method of delivery a provocatively effective amount of a bronchially provocative agent to the lung of a patient which comprises the use of a metering inhaler.
  • metering inhaler we mean any conventionally known inhaler which is capable of delivering combined metering and delivery of an active agent.
  • the inhaler may be a metered dose inhaler, a dry powder inhaler, an insufflator or nebuliser, or any other conventionally known type of inhaler.
  • a preferred inhaler is a dry powder inhaler (DPI).
  • bronchially provocative agent we mean any conventionally known materials used in a challenge test, e.g. PC 2 o or PD 20 tests. Such materials are well known to those skilled in the art.
  • certain agents which may be mentioned include, by way of example only, methacholine, or a salt thereof, histamine, or a salt thereof, adenosine monophosphate, sodium metabisulphite and conventionally known allergens.
  • methacholine, or a salt thereof Conventionally known salts of methacholine may be used in accordance with the invention;, but the halide salts are preferred, e.g. the bromide or chloride and especially the chloride.
  • bronchially provocative agent may delivered alone, however, it may be advantageous for the bronchially provocative agent to be administered in conjunction with a carrier material.
  • a formulation suitable for administration in dry powder form which comprises an effective amount of a bronchially provocative agent in admixture with a suitable adjutant diluent or carrier.
  • a suitable adjutant diluent or carrier Any conventionally known adjuvant, diluent or carrier materials may be used, such materials which may be mentioned include, but are not limited to, sugars, e.g. dextran, mannitol and lactose.
  • the amount of the bronchially provocative agent in such an admixture may vary and may therefore range from the pure bronchially provocative agent to an admixture containing up to 0.1 % w/w of the bronchially provocative agent.
  • a bronchially provocative agent in the manufacture of a composition as hereinbefore described.
  • methacholine, or a salt thereof, e.g. methacholine chloride in the manufacture of a composition as hereinbefore described.
  • the amount of the bronchially provocative agent administered may vary, but will generally be in the range of from 0.008 to 6.56mg, preferably from 0.008 to 4.2mg.
  • the method and composition of the inventions is especially advantageous in that, inter alia, it provides an efficient and accurate technique for the measurement of PC 2 o or PD 2 o in a patient.
  • a medicament delivery device which comprises a sealed medicament reservoir containing a predetermined dosage of a medicament delivery passage and means for opening the sealed reservoir.
  • the medicament reservoir preferentially comprises a chamber, one wall of which comprises a thin material.
  • the thin material may be frangible, however it is preferred the thin material is, for example, a thin film which is bonded to the chamber and may be removed by breaking the bond, e.g. by peeling away.
  • the film may be a thin plastics material or, preferably, a thin foil such as aluminium foil.
  • the film may be conventionally bonded to the medicament chamber, e.g. by adhesive, heat bonding or crimping.
  • the medicament reservoir preferably is a strip comprising a plurality of medicament chambers.
  • the number of chambers may vary, however for use in the delivery of a bronchially provocative agent, the optimum number of chambers is five since, conventionally, a patient is required to receive, for example, five doses of the bronchially provocative agent.
  • the delivery device is preferably an inhaler and especially a dry powder inhaler.
  • dry powder we mean an agent in finely divided form.
  • a variety of medicaments may be separately administered by using the inhaler of the invention, optionally with a conventionally known pharmaceutically acceptable adjuvant, diluent or carrier.
  • Such medicaments are generally, bronchodilators of other anti- asthma drugs and antibiotics.
  • Such medicaments include, but are not limited to ⁇ 2 - agonists, e.g.
  • fenoterol formoterol, pirbuterol, reproterol, rimiterol, salbutamol, salmeterol and terbutaline; non-selective beta-stimulants such as isoprenaline; xanthine bronchodilators, e.g. theophylline, aminophylline and choline theophyllinate; anticholinergics, e.g. ipratropium bromide; mast cell stabilisers, e.g. sodium cromoglycate and ketotifen; bronchial anti-inflammatory agents, e.g. nedocromil sodium; and steroids, e.g. beclomethasone dipropionate, fluticasone, budesonide and flunisolide; and combinations thereof.
  • non-selective beta-stimulants such as isoprenaline
  • xanthine bronchodilators e.g. theophylline, aminophylline and
  • medicaments which may be mentioned include combinations of steroids, such as, beclomethasone dipropionate, fluticasone, budesonide and flunisolide; and combinations of to ⁇ -agonists, such as, formoterol and salmeterol. It is also within the scope of this invention to include combinations of one or more of the aforementioned steroids with one or more of the aforementioned ⁇ 2 -agonists.
  • steroids such as, beclomethasone dipropionate, fluticasone, budesonide and flunisolide
  • to ⁇ -agonists such as, formoterol and salmeterol. It is also within the scope of this invention to include combinations of one or more of the aforementioned steroids with one or more of the aforementioned ⁇ 2 -agonists.
  • the inhaler of the invention is especially suitable for use in conjunction with a bronchially provocative agent, e.g. in Challenge tests. However, it is also useful in the treatment or alleviation of respiratory disorders.
  • a bronchially provocative agent e.g. in Challenge tests.
  • it is also useful in the treatment or alleviation of respiratory disorders.
  • a method of treatment of a patient with a respiratory disorder which comprises the administration of a combination of medicaments using an inhaler as hereinbefore described. It is an especially advantageous feature of the invention to provide a prefilled inhaler in accordance with invention.
  • a prefilled DPI and particularly a DPI prefilled with a bronchially provocative agent e.g. methacholine or a salt thereof.
  • a Challenge test kit which comprises a prefilled DPI as hereinbefore described.
  • the kit may optionally include a plurality of such DPIs which may be individually wrapped and sealed.
  • the kit may also include colour coding to signify the dosage contained in the prefilled DPI.
  • Figure 1 is a cut-away perspective representation of an inhaler of the invention
  • Figure 2 is a perspective representation of an inhaler of the invention
  • Figure 3 is a schematic representation of the use of the kit of the invention in a methacholine test.
  • an inhaler (1) is provided with a mouthpiece (2) and an operating handle (3).
  • the inhaler (1) comprises a first end (4) and a second, mouthpiece end (12).
  • the first end (4) is provided with a conduit (5) for receiving a cartridge ship (6) of medicament chambers (7).
  • the cartridge strip (6) is provided with a foil seal (8) along one wall.
  • the foil is crimped (8a) to provide a traction point.
  • the inhaler (1) is provided with a lip (9) which partially protrudes into the conduit (5).
  • the lip (9) is positioned at the open end (10) of a closed passage (11).
  • the conduit (5) divides into a closed cavity (13) and an airway or inhalation passage (14).
  • Adjacent to lip (9) the inhaler (1) is provided with a foil collection drum (15) which is mounted on a rotatable axis (16).
  • the drum (15) is provided with an operating handle (3) which itself comprises a shaft (18) attached a moveable wall portion (19) of the inhaler (1).
  • a cartridge (6) is placed in the conduit (5) and pushed up against the lip (9).
  • the lip (9) is positioned such that it slides between the foil cover (8) and the chamber walls of the cartridge (6).
  • the medicament (not shown) in the first chamber is exposed, the patient inhales through the mouthpiece (12).
  • the medicament is drawn from the chamber (7), through the inhalation passage (14) and exits the passage through the mouthpiece (12).
  • the patient then raises the moveable wall (19) and is able to rotate the foil collection drum (15). Once the end (8b) of the foil (8) has engaged with the drum (15), rotation of the drum (15) winds the foil (8) in, which acts to pull the cartridge (6) down the conduit (5) and exposes the medicament in the next chamber (7). The patient inhales and the process is repeated.
  • Figures 3 a) and b) illustrate an inhaler (1) and a medicament cartridge (6) respectively.
  • the correct dosage cartridge is inserted in the conduit (Fig. 3c) and the inhaler is primed ready for use and then sealed in a foil package (Fig. 3d).
  • the packs and/or inhalers may preferentially be colour coded (Fig. 3e) to identify the dosage of drug filled into the cartridge chambers. Similarly colour coded packs may then be placed in a holding tray (Fig. 3f).
  • a patient is provided with the relevant dosage indicated inhaler.
  • the foil seal is broken (Fig. 3g) and the inhaler removed from the package.
  • the patient lifts the lever (Fig. 3h) to prime the first chamber and then inhales through the mouthpiece (Fig. 3i).

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pulmonology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Anesthesiology (AREA)
  • Otolaryngology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne un procédé permettant d'effectuer un test de stimulation des bronches qui consiste à doser et à administrer à un patient une quantité d'agent stimulant efficacement les bronches. L'invention concerne également un dispositif d'administration de médicament qui comporte un réservoir à médicament clos dans lequel se trouve un dosage préétabli d'une formule de libération de médicament et un système d'ouverture du réservoir.
PCT/GB2001/002648 2000-06-19 2001-06-19 Administration d'agents stimulant les bronches Ceased WO2001097887A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2001266143A AU2001266143A1 (en) 2000-06-19 2001-06-19 Delivery of bronchially provocative agents

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0014898A GB0014898D0 (en) 2000-06-19 2000-06-19 Delivery system
GB0014898.1 2000-06-19

Publications (1)

Publication Number Publication Date
WO2001097887A1 true WO2001097887A1 (fr) 2001-12-27

Family

ID=9893898

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2001/002648 Ceased WO2001097887A1 (fr) 2000-06-19 2001-06-19 Administration d'agents stimulant les bronches

Country Status (3)

Country Link
AU (1) AU2001266143A1 (fr)
GB (1) GB0014898D0 (fr)
WO (1) WO2001097887A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003039636A1 (fr) * 2001-11-02 2003-05-15 Eli Lilly And Company Dose therapeutique chromocodee
US9179691B2 (en) 2007-12-14 2015-11-10 Aerodesigns, Inc. Delivering aerosolizable food products
WO2016180975A1 (fr) * 2015-05-14 2016-11-17 Medical Graphics Italia S.R.L. Équipement de réalisation d'une provocation bronchique à la méthacholine et dispositif contenant de la méthacholine
WO2017046649A1 (fr) * 2015-09-16 2017-03-23 1355540 Ontario Inc. Système et procédé de distribution de poudre sèche
WO2018061022A1 (fr) 2016-09-28 2018-04-05 Indian Institute Of Technology, Guwahati Dispositif de surveillance d'état pulmonaire

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5570683A (en) * 1990-12-05 1996-11-05 The General Hospital Corporation Methods and devices for treating pulmonary vasoconstriction and asthma
US5694920A (en) * 1996-01-25 1997-12-09 Abrams; Andrew L. Inhalation device
US5747002A (en) * 1995-04-05 1998-05-05 Genentech, Inc. Preparation of sodium chloride aerosol formulations
US5817028A (en) * 1994-02-25 1998-10-06 Central Sydney Area Health Service Method and device for the provocation of air passage narrowing and/or the induction of sputum
US6070575A (en) * 1998-11-16 2000-06-06 Aradigm Corporation Aerosol-forming porous membrane with certain pore structure
WO2000062819A1 (fr) * 1999-04-21 2000-10-26 1355540 Ontario Inc. Formulations pour detecter l'asthme

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5570683A (en) * 1990-12-05 1996-11-05 The General Hospital Corporation Methods and devices for treating pulmonary vasoconstriction and asthma
US5817028A (en) * 1994-02-25 1998-10-06 Central Sydney Area Health Service Method and device for the provocation of air passage narrowing and/or the induction of sputum
US5747002A (en) * 1995-04-05 1998-05-05 Genentech, Inc. Preparation of sodium chloride aerosol formulations
US5694920A (en) * 1996-01-25 1997-12-09 Abrams; Andrew L. Inhalation device
US6070575A (en) * 1998-11-16 2000-06-06 Aradigm Corporation Aerosol-forming porous membrane with certain pore structure
WO2000062819A1 (fr) * 1999-04-21 2000-10-26 1355540 Ontario Inc. Formulations pour detecter l'asthme

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, vol. 156, no. 3 PART 1, 1997, pages 758 - 765, XP002177457, ISSN: 1073-449X *
DATABASE BIOSIS [online] BIOSCIENCES INFORMATION SERVICE, PHILADELPHIA, PA, US; 1997, ANDERSON SANDRA D ET AL: "A new method for bronchial-provocation testing in asthmatic subjects using a dry powder of mannitol.", XP002177458, Database accession no. PREV199799761937 *

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003039636A1 (fr) * 2001-11-02 2003-05-15 Eli Lilly And Company Dose therapeutique chromocodee
US9179691B2 (en) 2007-12-14 2015-11-10 Aerodesigns, Inc. Delivering aerosolizable food products
WO2016180975A1 (fr) * 2015-05-14 2016-11-17 Medical Graphics Italia S.R.L. Équipement de réalisation d'une provocation bronchique à la méthacholine et dispositif contenant de la méthacholine
WO2017046649A1 (fr) * 2015-09-16 2017-03-23 1355540 Ontario Inc. Système et procédé de distribution de poudre sèche
WO2018061022A1 (fr) 2016-09-28 2018-04-05 Indian Institute Of Technology, Guwahati Dispositif de surveillance d'état pulmonaire
US11432744B2 (en) 2016-09-28 2022-09-06 Indian Institute Of Technology, Guwahati Lung condition monitoring device

Also Published As

Publication number Publication date
AU2001266143A1 (en) 2002-01-02
GB0014898D0 (en) 2000-08-09

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